A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder

Trial Profile

A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs Vibegron (Primary) ; Tolterodine
  • Indications Overactive bladder
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 06 Jun 2017 According to a Roivant Sciences media release, the primary endpoints of Micturition rate, Change from Baseline in Average Daily Micturitionssafety issue No time frame: Baseline and Week 8, Base Study: Number of Participants Who Experienced an Adverse Event (AE) and/ or Serious Adverse Event (SAE) and Base Study: Number of Participants Who Discontinued the Study Due to an AE and/or SAE has been met.
    • 24 Jun 2016 Time frame for primary endpoints changed, number of treatment arms changed from 12 to 15
    • 01 Oct 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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